DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 6, 2026 has been entered.
Response to Arguments
Applicant’s arguments, see amendment and remarks, filed April 6, 2026, with respect to the specification objection(s) have been fully considered and are persuasive. The specification objection has been withdrawn.
Applicant’s arguments, see amendment and remarks, filed April 6, 2026, with respect to the rejection of claims 21-22, 24-25, 27-30 and 32-34 under 35 U.S.C. 102(a)(1) as being anticipated by Austin et al. U.S. publication no. 2016/0045324 A1 (“Austin”); rejection of claim 23 under 35 U.S.C. 103 as being unpatentable over Austin; rejection of claims 26 and 31 under 35 U.S.C. 103 as being unpatentable over Austin in view of Champagne et al. U.S. publication no. 2019/0070013 A1 (“Champagne”); rejection of claim 35 under 35 U.S.C. 103 as being unpatentable over Austin ”) in view of Barry et al. U.S. publication no. 2017/0348032 A1 (“Barry”); and rejection of claims 36-38 under 35 U.S.C. 103 as being unpatentable over Austin in view of Dixon et al. U.S. patent no. 6,695,845 B2 (“Dixon”) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of additional prior art and/or considerations.
Priority
This application appears to disclose and claim one of a substantial portion of prior Application No. 18/053,883, filed November 9, 2022 [and including provisional and prior PCT applications related thereto] or only subject matter disclosed in said prior Application No. 18/053,883, filed November 9, 2022 [and including provisional and prior PCT applications related thereto] and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute either a continuation or divisional or continuation-in-part of the prior application. Should Applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-25, 27, 29, 30, 32-34 and 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Shemwell et al. U.S. publication no. 2015/0142066 A1 (“Shemwell”) in view of Austin et al. U.S. publication no. 2016/0045324 A1 (“Austin”).
Regarding claims 21 and 39, Shemwell discloses a method of digital arthrodesis or hammertoe correction (paragraphs [0115]-[0116]), comprising: accessing a proximal interphalangeal joint between a middle phalanx and a proximal phalanx [using at least blade 402] (e.g., see at least paragraphs [0089] and [0118]-[0119]; and figures 37 and 39, etc.); inserting a first K-wire (10-1) into the middle phalanx (304) (e.g., see at least paragraphs [0090]-[0091] and [0120]); drilling and/or tapping a first aperture within the middle phalanx and/or resecting bone and/or cartilage from the middle phalanx using one or more instruments (e.g., see at least figure 14; and paragraphs [0026], [0091], [0101], etc.); inserting a second K-wire (10-2) into the proximal phalanx (e.g., see at least paragraph [0121]); drilling and/or tapping a second aperture within the proximal phalanx (302) and/or resecting bone and/or cartilage from the proximal phalanx (302) using one or more instruments (e.g., see at least figure 15; and paragraphs [0090], [0100], [0105], [0119], etc.); inserting a threaded proximal portion (102) of a cannulated implant (100A) over the second K-wire (10-2) within the second aperture of the proximal phalanx (302) (e.g., see at least figure 42A; and paragraphs [0122], etc.); inserting an end (10B-1) of the first K-wire (10-1) into a passage (101) of the cannulated implant (100A) (e.g., see at least figure 43; and paragraph [0124]); after inserting the threaded proximal portion (102) of the cannulated implant (100A) within the second aperture of the proximal phalanx (302) (figures 37 and 42), inserting a distal portion (104) of the cannulated implant (100A) within the first aperture of the middle phalanx (304) over the first K-wire (10-1), wherein the distal portion (104) is shorter in length than the threaded proximal portion (102) (e.g., see at least figures 42-43, etc.); and manually compressing the distal portion (104) of the cannulated implant (100A) within the middle phalanx (304) (e.g., see at least paragraphs [0091], [0101], etc.).
Shemwell is silent regarding the one or more instruments for preparing the middle phalanx and proximal phalanx being inserted over first and second K-wires, respectively, substantially as claimed.
In the same field of endeavor, namely digital arthrodesis or hammertoe correction procedures, Austin teaches drilling and/or tapping a first aperture within the middle phalanx and/or resecting bone and/or cartilage from the middle phalanx using one or more instruments inserted over the first K-wire (e.g., see at least paragraph [0066]); and drilling and/or tapping a second aperture within the proximal phalanx and/or resecting bone and/or cartilage from the proximal phalanx using one or more instruments inserted over the second K-wire (e.g., see at least paragraph [0066]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to use a guide wire to assist in instrument placement for preparing the bones in the invention of Shemwell, as taught and/or suggested by Austin in order to aid in proper placement and positioning with predictable results and a reasonable expectation of success.
Regarding claim 22, Shemwell discloses the first K-wire (10-1) is inserted through a proximal portion of the middle phalanx (304) and out past a distal end of a distal phalanx (306) (e.g., see at least paragraphs [0120]; and figures 37 and 40, etc.).
Regarding claim 23, Shemwell discloses the method further comprising advancing the first K-wire (10-1) into the middle phalanx (304) and across a metatarsophalangeal joint (figures 40 and 43-44) after inserting the threaded proximal portion (102) of the cannulated implant (100A) into the second aperture of the proximal phalanx (302) (figures 37 and 41-46).
Regarding claims 24 and 40, Shemwell discloses the middle phalanx (304) is distracted distally to advance the distal portion (104) of the cannulated implant (100A) into the first aperture of the middle phalanx (304) (e.g., see at least figures 37 and 42-44).
Regarding claim 25, as described supra, Shemwell in view of Austin teaches the invention substantially as claimed. Shemwell is further silent regarding the method further comprising radiographically checking that the second K-wire is centered on a face and/or at a correct depth within the proximal phalanx substantially as claimed.
Austin teaches the method further comprising radiographically (i.e., with fluoroscopic views) checking that the second K-wire is centered on a face and/or at a correct depth within the proximal phalanx (e.g., see at least paragraph [0066]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to use radiography to check that the second K-wire (10-2 of Shemwell) is centered on a face and/or at a correct depth within the proximal phalanx, as taught and/or suggested by Austin, to ensure a safe surgical procedure with predictable results and a reasonable expectation of success.
Regarding claim 27, Shemwell discloses the cannulated implant (100A) has a transition portion positioned between the threaded proximal portion (102) and the distal portion (104), wherein the transition portion comprises a bend [i.e., is “angled”] (e.g., see at least paragraphs [0079], [0081], [0094], [0113]).
Regarding claims 29 and 41, Shemwell discloses the cannulated implant (100A) includes a finned portion (104) positioned along the distal portion (104), the finned portion configured to prevent migration and/or rotation of the implant in use (e.g., see at least paragraphs [0081]-[0082], etc.; and figures).
Regarding claim 30, Shemwell discloses the threaded proximal portion (102) comprises a first cross-sectional shape (e.g., see at least figures showing cylindrical shape of threaded portion); and the finned portion (104) comprises a second cross-sectional shape (e.g., see at least figures; and paragraphs [0081], [0083] and [0129]-[0131]).
Regarding claim 32, Shemwell discloses the passage (101) extends linearly from a proximal end of the implant to a distal end of the implant (e.g., see at least paragraph [0115] and figures 42, 44 and 45).
Regarding claims 33 and 34, as described supra, Shemwell in view of Austin teaches the invention substantially as claimed. Shemwell is silent regarding any material from which the invention is created. However, Austin further teaches suitable materials for an implant comprises a metallic material or a polymeric material (e.g., see at least paragraphs [0011], [0027]-[0028], [0046], etc.). Moreover, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to select at least one of metal or a polymer as a suitable material for formation of the invention implant in order to select a known biocompatible material for implant use with predictable results and a reasonable expectation of success.
Claims 26 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Shemwell et al. U.S. publication no. 2015/0142066 A1 (“Shemwell”) in view of Austin et al. U.S. publication no. 2016/0045324 A1 (“Austin”), as applied above, and further in view of Champagne et al. U.S. publication no. 2019/0070013 A1 (“Champagne”).
Regarding claims 26 and 31, as described supra, Shemwell in view of Austin teaches the method substantially as claimed. Shemwell further discloses the first-cross sectional shape comprises a circle (e.g., see at least cylindrical shape of threaded element 102). Shemwell further discloses the second cross sectional shape of the blade portion 104 may have cross-sectional shapes other than a circle (e.g., see at least paragraphs [0081], [0083], etc.) However, Shemwell is silent regarding the second-cross sectional shape specifically comprises an oval substantially as claimed.
In the same field of endeavor, namely phalange implants, Champagne teaches using a second cross-sectional shape comprising an oval (e.g., see at least paragraph [0025]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to form the second-cross-sectional shape in the invention of Shemwell in view of Austin as an oval, as taught and/or suggested by Champagne, in order to, among other things, aid in torsional stability with predictable results and a reasonable expectation of success.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Shemwell et al. U.S. publication no. 2015/0142066 A1 (“Shemwell”) in view of Austin et al. U.S. publication no. 2016/0045324 A1 (“Austin”), as applied above, and further in view of Barry et al. U.S. publication no. 2017/0348032 A1 (“Barry”).
Regarding claim 35, as described supra, Shemwell in view of Austin teaches the invention substantially as claimed. Shemwell in view of Austin is silent regarding the implant comprises an allograft material substantially as claimed. In the same field of endeavor, namely implants for correcting hammertoe and other deformities (e.g., see at least paragraph [0067]), Barry teaches an implant may comprise an allograft material (e.g., see at least paragraphs [0116]-[0117]). Moreover, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Thus, it would have been obvious to one ordinary skill in the art at the time of the effective filing date of the claimed invention to form the implant comprising an allograft material as a known, suitable material selectable as a biocompatible material that may be desired for integration of the implant over time with predictable results and a reasonable expectation of success.
Claims 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Shemwell et al. U.S. publication no. 2015/0142066 A1 (“Shemwell”) in view of Austin et al. U.S. publication no. 2016/0045324 A1 (“Austin”), as applied above, and further in view of Dixon et al. U.S. patent no. 6,695,845 B2 (“Dixon”).
Regarding claims 36-38, as described supra, Shemwell in view of Austin teaches the invention substantially as claimed. Shemwell in view of Austin is silent regarding the first and second instruments are a one-step drill, tap and reamer substantially as claimed.
In the same field of endeavor, namely bone implants, Dixon teaches an instrument formed as a one-step drill, tap and reamer (e.g., see at least figures 11; and col. 9, lines 5-6).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to use an instrument with features as taught and/or suggested by Dixon in the method of Shemwell in view of Austin in order to minimize the tooling and steps necessary to prepare the bone for implant insertion with predictable results and a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA LYNN WATKINS whose telephone number is (571)270-1456. The examiner can normally be reached Mon. & Tues. 3-8pm and Thurs. 12-6pm.
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/MARCIA L WATKINS/Primary Examiner, Art Unit 3774
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